Petrarca Robert, Dugel Pravin U, Bennett Michael, Barak Adiel, Weinberger Dov, Nau Jeffrey, Jackson Timothy L
*Department of Ophthalmology, King's College Hospital, London, United Kingdom; †King's College London, London, United Kingdom; ‡Retinal Consultants of Arizona, Phoenix, Arizona; §Retina Institute of Hawaii, Honolulu, Hawaii; ¶Tel Aviv Sourasky Medical Center, Tel Aviv, Israel; **Rabin Medical Center, Tel Aviv, Israel; and ††NeoVista, Newark, California. J. Nau is now an employee at Genentech, South San Francisco, California.
Retina. 2014 May;34(5):874-9. doi: 10.1097/IAE.0000000000000026.
To evaluate the safety and efficacy of epimacular brachytherapy for the treatment of chronic, active neovascular age-related macular degeneration.
A prospective, multicenter, interventional noncontrolled clinical trial recruited 53 participants with previously treated neovascular age-related macular degeneration. Participants underwent pars plana vitrectomy with a single 24 Gray dose of epimacular brachytherapy, delivered using an intraocular cannula containing a Strontium 90/Yttrium 90 source that was positioned over the active lesion. Participants were retreated with ranibizumab, administered monthly as needed, using predefined retreatment criteria. Coprimary outcomes at 24 months were the proportion of participants losing <15 Early Treatment of Diabetic Retinopathy Study letters and mean number of ranibizumab retreatments.
Over 24 months, 68.1% lost <15 letters with a mean of 8.7 ranibizumab retreatments. Mean change in visual acuity was -6.3 (standard deviation, 18.9) letters. There was one case of nonproliferative radiation retinopathy.
The apparent reduction in ranibizumab retreatment was less evident in Year 2 than Year 1, with the moderate reduction in visual acuity extending into the second year. Although radiation retinopathy occurred in one case, it was not vision threatening and safety remained acceptable.
评估黄斑部近距离放射治疗慢性活动性新生血管性年龄相关性黄斑变性的安全性和有效性。
一项前瞻性、多中心、非对照介入性临床试验招募了53例先前接受过治疗的新生血管性年龄相关性黄斑变性患者。患者接受了玻璃体切除术，并使用含有锶90/钇90源的眼内插管进行单次24格雷剂量的黄斑部近距离放射治疗，该插管置于活动性病变上方。根据预先定义的再治疗标准，必要时每月给予雷珠单抗进行再治疗。24个月时的共同主要结局是视力下降<15个糖尿病视网膜病变早期治疗研究字母的患者比例以及雷珠单抗再治疗的平均次数。
在24个月期间，68.1%的患者视力下降<15个字母，雷珠单抗再治疗的平均次数为8.7次。视力的平均变化为-6.3（标准差，18.9）个字母。有1例非增殖性放射性视网膜病变。
雷珠单抗再治疗次数的明显减少在第2年不如第1年明显，视力的中度下降持续到第2年。虽然发生了1例放射性视网膜病变，但未威胁视力，安全性仍然可以接受。
